Premier Research is looking for a Associate Manager, Clinical Data Sciences to join our Clinical Data Sciences team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What you'll be doing:

• Serves as primary Clinical Data Sciences contact in assigned studies and ensures that data cleaning is performed in a consistent way between team members

• Coordinates all tasks within the data science process between different team members from database development to database lock

• Prepares data management plans, completion guidelines, data reports and other documents required for preparing and completing databases

• Supports database development activities and coordinates database amendments in collaboration with the database development team

• Supports department management in resource planning and allocation; hiring and management of data management staff; and achievement of department financial goals

• Participates in project costing estimates and proposal review in the business development/change order process

What we are searching for:

• Bachelor’s Degree or above (preferably in a Life Science)

• 6-8 years mastery in data management experience, with at least 0-2 years of supervisory/management experience

• Experience working within at least two clinical data management systems and in-depth knowledge of at least one, preferably Medidata Rave or Calyx EDC

• Familiar with all phases of a study, e.g., study startup/database setup, maintenance, and lock

• Knowledge of data mining and the application of data standards desirable

• Knowledge of ICH / GCP regulations, in particular ICH E6

• Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, General Data Protection Regulation (GDPR) requirements

• Willingness to travel

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $90,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status